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Study on chronic hepatitis Ctreatment with interferon alpha, ribavirin and amantadine in naive patients.


- candidate number1238
- NTR NumberNTR145
- ISRCTNISRCTN74271466
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR25-aug-2005
- Secondary IDsN/A 
- Public TitleStudy on chronic hepatitis Ctreatment with interferon alpha, ribavirin and amantadine in naive patients.
- Scientific TitleStudy on chronic hepatitis Ctreatment with interferon alpha, ribavirin and amantadine in naive patients.
- ACRONYMCIRA-study
- hypothesisAdding amantadine to the standard anti-HCV treatment can improve sustained response rates in chronic hepatitis C.
- Healt Condition(s) or Problem(s) studiedHepatitis C
- Inclusion criteria1. Anti-HCV positivity; >6 months;
2. ALT and/or AST elevation on at least once in the previous 6 months;
3. Positive HCV-RNA;
4. Liver biopsy within one year before the start of therapy in non-cirrhosis;
In the case of known cirrhosis, liver biopsy is not necessary;
5. Intention to be treated and participate treatment;
6. Obtained written informed consent.
- Exclusion criteria1. Age < 18 years;
2. Pregnancy or intention to get pregnant within the 12 months period of treatment and up to 6 months after discontinuation of therapy, no adequate contraception, lactation;
3. Men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy;
4. Life expectancy < 1 year;
5. Child Pugh B or C (Appendix III);
6. Creatinine > 150 ýmol/L or > 1.70 mg/dl;
7. Haemoglobulin < 6.5 mmol/l or < 10.5 g/dl, white blood cell count < 2,5 x 109/L, neutrophil < 1,5 x 109/L, platelet count < 70 x 109/L;
8. HIV positivity;
9. Chemotherapy, systemical antiviral treatment during the 6 months prior to study entry;
10. Other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arythmias);
11. Active uncontrolled psychiatric disorders and suicidal leanings;
12. Patients with a history of uncontrolled seizure or other significant CNS dysfunction;
13. Any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 14-feb-2000
- planned closingdate1-mei-2007
- Target number of participants390
- InterventionsOne year treatment with interferon/ribavirin and amantadine or placebo.
- Primary outcomeVirological response at week 52 and 104.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. K.J. Erpecum, van
- CONTACT for SCIENTIFIC QUERIES H. Soest, van
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsN/A
- Brief summaryThis is a double blind, placebo controlled, randomised, multicentre study in previously untreated patients suffering from chronic hepatitis C comparing double therapy, consisting of interferon alpha 2b (Intron-A«) and ribavirin (Rebetol«), with triple therapy, consisting of interferon alpha 2b, ribavirin and amantadine, for 52 weeks. Follow-up is completed at week 104.
150 subjects per treatment group will be included. Patients will be stratified before randomisation according to genotype (1 versus non-1).
Viral load will not be a discriminating factor.

The aim is to investigate the efficacy of the adjunct amantadine to the currently used combination therapy with interferon alpha and ribavirin.
- Main changes (audit trail)
- RECORD18-aug-2005 - 29-nov-2009


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